Hyperglycemia, Obesity Prevention
Conditions
Keywords
meal replacement, glucose regulation
Brief summary
Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets. The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults. Subjects: 40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 . Protocol: This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.
Interventions
DIETARY_SUPPLEMENTpowder shake with very low glycemic index
2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged.
DIETARY_SUPPLEMENTCeral Breakfast
consume of 400kcal of oat-based cereal with honey for breakfast
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 25-40 * Eating pattern 3 meals a day * stable weight for the last 2 months (\<5 pounds fluctuation) * Willing to eat oat cereal for breakfast * glycated hemoglobin \<7%
Exclusion criteria
* glycated hemoglobin \>7% * Body mass index ≤25 or ≥ 40 * Night shifting work * Atypical meal pattern (not three meals a day or intermittent fasting) * Thyroid medication * Bariatric surgery * Habitual strenuous exercise * Commuting by bicycle * Eating disorders * Use of aspirin during the duration of the study * Intake of Vit C \>60 mg/day during the study * cancer * cardiovascular disease * renal disease * hepatic disease * X-ray, MRI or CT appointment during the study duration * Current infection requiring medication * Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV * Medications of supplements that could affect body weight or appetite (i.e. Ozempic) * Participating in another study at the same time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose response between two breakfasts | the entire 2 hours of the glycemic test | The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion. |
| Insulin responses between the two breakfasts | The entire 2 hours period | The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion. |
| Glucose réponses during glucose challenge test | 2 hours post ingestion of the emperimental meal (cereal or ceral + shake) | Positive integer of the area under the curve for glucose during the 2 hours glycemic test |
| Insulin responses during the glucemic challenge test | 2 hour post ingestion of the intervention meal (cereal or cereal + shake) | Positive integer of the area under the curve for insulin during the 2-hours glycemic test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory glucose profile | total area under the curve during the 2 weeks (14 days) of dietary intervention. | The difference between the two groups on the area under the curve in Ambulatory glucose measured with a continuous glucose monitor during the 2 weeks of dietary intervention. |
| Blood glucagon | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood glucagon difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| Glucagon like peptide 1 | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood Glucagon like peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| Leptin | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood Leptin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| Adiponectin | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood Adiponectin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| Ghrelin | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood Ghrelin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
| C-Peptide | 0, 30, 60, 90, and 120 minutes of the glycemic test. | Blood c-peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake) |
Countries
United States
Outcome results
None listed